NCT01092663

The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

The Effects of Co-administration of Colesevelam and Sitagliptin on Glucose Metabolism in Patients With Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: KineMed · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

Detailed description

The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by 1. improving the effects of colesevelam on fasting glucose metabolism 2. improving the effects of colsevelam on postprandial glucose metabolism

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Colesevelam HCl	Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
DRUG	Sitagliptin	Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-03-25
• Last updated: 2013-01-17
• Results posted: 2013-01-17

Locations

3 sites across 1 country: United States